Radiographic Progression-Free Survival as a Clinically Meaningful End Point in Metastatic Castration-Resistant Prostate Cancer: The PREVAIL Randomized Clinical Trial.

ABSTRACT:

Importance

Drug development for metastatic castration-resistant prostate cancer has been limited by a lack of clinically relevant trial end points short of overall survival (OS). Radiographic progression-free survival (rPFS) as defined by the Prostate Cancer Clinical Trials Working Group 2 (PCWG2) is a candidate end point that represents a clinically meaningful benefit to patients.

Objective

To demonstrate the robustness of the PCWG2 definition and to examine the relationship between rPFS and OS.

Design, setting, and participants

PREVAIL was a phase 3, randomized, double-blind, placebo-controlled multinational study that enrolled 1717 chemotherapy-naive men with metastatic castration-resistant prostate cancer from September 2010 through September 2012. The data were a

SUBMITTER: Rathkopf DE 

PROVIDER: S-EPMC5885186 | biostudies-literature | 2018 May

REPOSITORIES: biostudies-literature